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Building an Ecosystem to Enable, Encourage and Support
New Products for AA
William Ju MD, FAAD
Advancing Innovation in Dermatology, Inc.
ALOPECIA AREATA RESEARCH SUMMIT
November 14, 2016
Disclosures
Advancing Innovation in Dermatology, Inc. ^ #
Aclaris Therapeutics, Inc. *
Amicus Pharmaceuticals, Inc. *
Brickell Biotech, Inc. ^ * +
^ Board of Directors/Trustees
# Officer (President)
* Consultant
+ Equity Ownership
2
Advancing Innovation in Dermatology (AID)
Topic: “Building an Ecosystem to Enable, Encourage and Support
New Products for AA”
AID Mission: Advancing Innovation in Dermatology is a non-
profit organization with a mission to help grow an ecosystem for
creating and bringing to market an increased number of
innovative and scientifically-based products that substantially
improve dermatologic health
Why Build Collaboration Ecosystem for Dermatology ?
Product Innovation Can Be Complex and Costly
“Cost of bringing drug to market tops $2.5b, research finds”
By Robert Weisman, Boston Globe, November 18, 2014
4
• If this is true (even within an
order of magnitude), a daunting
amount
• Proactively building ecosystem
can help facilitate finding
resources and backing to
support innovative and
impactful product development
Ecosystem For Innovative Product Flow:
Technical and Financial Streams
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
5
Technical Stream
Financial Stream
Earlier-Stage Development
Dermatology Innovation Forum
6
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
Dermatology Innovation Forum
March – AAD Annual Meeting
Technical Stream
Financial Stream
Later-Stage Development
Dermatology Summit
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic
Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
Dermatology Summit
January – JP Morgan Healthcare Conference
7
Technical Stream
Financial Stream
Product Innovation Ecosystem
Dermatology is an Attractive Investment Area
• Dermatology product innovation can attract investment; in 2016
– M&A: Pfizer acquired Anacor - $5.2 Billion purchase price
– IPO: Novan – $ 330 Million market capitalization
– Venture capital investment: Sienna Pharmaceuticals $ 46 Million Series A round
• Products investable in for dermatology span a range of conditions
– Actavis acquired Allergan
• $ 70 Billion purchase price
• Dermatology aesthetic products major revenue source
– Amicus Therapeutics acquired Scioderm
• $230 Million upfront payment (plus $ 620 Million for additional milestones)
• Orphan disease - epidermolysis bullosa
8
Alopecia Areata Research Summit – Product Innovation Ecosystem
Identifying and Defining the Problems Worth Solving
9
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
Dermatology Innovation Forum
March – AAD Annual Meeting
Technical Stream
Financial Stream
• Technical stream: unmet medical need
• Financial stream: pain point
• NAAF Alopecia Areata Research Summit
participants have profound insights of the problems
worth solving for AA
Alopecia Areata Research Summit – Product Innovation Ecosystem
Applying Know-How & Technology to Solve the Problem
• A deep understanding of biology of the disease pathophysiology can provide novel
targets and approaches that lead to treatment breakthroughs
• Multiple examples of this paradigm, upon which much of the biomedical
therapeutics industry is based
10
Basic
Research
Biology
Target ID
Target
Validation
Chemistry Development
Approved
Drug
Screening Optimization
Pre-
clinical
Phase
I
Phase
II
Phase
III
FDA
review
Eureka !
O
OCH3
OCH3
OCH3
OH
Alopecia Areata Research Summit – Product Innovation Ecosystem
Determining Clinical Research Approach for Product Innovation
• Key role for clinical outcome assessments in the path to regulatory approval
– Identifying what aspects of the disease need to be altered as priority by a new therapy
– Determining how to measure whether an intervention improves a disease dimension
• Validated outcome measures for treatments are important for
– Technical stream: e.g. for health authority product approval
– Financial stream: e.g. for determining a product’s value to patients and payers
• Particularly important without previous regulatory approvals and market launches11
Basic
Research
Biology
Target
ID
Target
Validatio
n
Chemistry Development
Approve
d DrugScreening Optimization
Pre-
clinical
Phase
I
Phase
II
Phase
III
FDA
review
Eureka !
O
OCH3
OCH3
OCH3
OH
Other Elements for Product Innovation
Inventions, Products, and Assets
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
12
Technical Stream
Financial Stream
O
OCH3
OCH3
OCH3
OH
Product
Asset
Advancing Product Development A Team Sport
Support and Enablement from the Ecosystem
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
13
Technical Stream
Financial Stream
O
OCH3
OCH3
OCH3
OH
Product
Asset
Cosmetics Devices
Diagnostics
Drugs/Biotechnology
eHealth
Govt / Nonprofit
Investor
OTC
Physician/Academician
Service Provider
Company/Organization Representation
~300 Registrants
Annual Dermatology Innovation Forum
Attendee Composition (March 2016 )
14
Participants include:
• Technical Stream
– Physicians
– Researchers
– Inventors
– Government regulators
• Financial Steam
– Investors
– Strategic corporate partners
• Bridging stakeholders
– Patient advocates
– Service providers
Sponsors of the 2017 Dermatology Summit &
Dermatology Innovation Forum
LEADERSHIP MAJOR
FOUNDING
SUPPORTING
Conference Benefactor
PREMIER
Conference Benefactor Conference Benefactor
Conference Benefactor
Conference Benefactor
Support and Enablement from the Ecosystem
Alopecia Areata Example
Research Center /
Entrepreneur
Discovery Regulatory
Approval
Invention Commer-
cialization
Late DevelopmentClinical POCEarly Development
Venture
Capital Firm
Strategic Partner
Angel Investor /
Patient Advocacy /
Impact Philanthropist
16
Technical Stream
Financial Stream
O
OCH3
OCH3
OCH3
OH
Product
Asset
Building an Ecosystem to
Enable, Encourage and Support New Products for AA
• Purposeful, proactively-built ecosystems can help enable productive
collaboration for advancing product innovation for substantially improving
dermatologic health
• Alopecia Areata Research Summit participants and NAAF are to be
commended for your
– Patient focus, breakthrough bench & clinical research, and other contributions
– Collaborative interactions and ecosystem building for bringing forth important
and impactful products for alopecia areata patients
17
Building an Ecosystem to Enable, Encourage and Support New Products for AA

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Building an Ecosystem to Enable, Encourage and Support New Products for AA

  • 1. Building an Ecosystem to Enable, Encourage and Support New Products for AA William Ju MD, FAAD Advancing Innovation in Dermatology, Inc. ALOPECIA AREATA RESEARCH SUMMIT November 14, 2016
  • 2. Disclosures Advancing Innovation in Dermatology, Inc. ^ # Aclaris Therapeutics, Inc. * Amicus Pharmaceuticals, Inc. * Brickell Biotech, Inc. ^ * + ^ Board of Directors/Trustees # Officer (President) * Consultant + Equity Ownership 2
  • 3. Advancing Innovation in Dermatology (AID) Topic: “Building an Ecosystem to Enable, Encourage and Support New Products for AA” AID Mission: Advancing Innovation in Dermatology is a non- profit organization with a mission to help grow an ecosystem for creating and bringing to market an increased number of innovative and scientifically-based products that substantially improve dermatologic health
  • 4. Why Build Collaboration Ecosystem for Dermatology ? Product Innovation Can Be Complex and Costly “Cost of bringing drug to market tops $2.5b, research finds” By Robert Weisman, Boston Globe, November 18, 2014 4 • If this is true (even within an order of magnitude), a daunting amount • Proactively building ecosystem can help facilitate finding resources and backing to support innovative and impactful product development
  • 5. Ecosystem For Innovative Product Flow: Technical and Financial Streams Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist 5 Technical Stream Financial Stream
  • 6. Earlier-Stage Development Dermatology Innovation Forum 6 Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist Dermatology Innovation Forum March – AAD Annual Meeting Technical Stream Financial Stream
  • 7. Later-Stage Development Dermatology Summit Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist Dermatology Summit January – JP Morgan Healthcare Conference 7 Technical Stream Financial Stream
  • 8. Product Innovation Ecosystem Dermatology is an Attractive Investment Area • Dermatology product innovation can attract investment; in 2016 – M&A: Pfizer acquired Anacor - $5.2 Billion purchase price – IPO: Novan – $ 330 Million market capitalization – Venture capital investment: Sienna Pharmaceuticals $ 46 Million Series A round • Products investable in for dermatology span a range of conditions – Actavis acquired Allergan • $ 70 Billion purchase price • Dermatology aesthetic products major revenue source – Amicus Therapeutics acquired Scioderm • $230 Million upfront payment (plus $ 620 Million for additional milestones) • Orphan disease - epidermolysis bullosa 8
  • 9. Alopecia Areata Research Summit – Product Innovation Ecosystem Identifying and Defining the Problems Worth Solving 9 Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist Dermatology Innovation Forum March – AAD Annual Meeting Technical Stream Financial Stream • Technical stream: unmet medical need • Financial stream: pain point • NAAF Alopecia Areata Research Summit participants have profound insights of the problems worth solving for AA
  • 10. Alopecia Areata Research Summit – Product Innovation Ecosystem Applying Know-How & Technology to Solve the Problem • A deep understanding of biology of the disease pathophysiology can provide novel targets and approaches that lead to treatment breakthroughs • Multiple examples of this paradigm, upon which much of the biomedical therapeutics industry is based 10 Basic Research Biology Target ID Target Validation Chemistry Development Approved Drug Screening Optimization Pre- clinical Phase I Phase II Phase III FDA review Eureka ! O OCH3 OCH3 OCH3 OH
  • 11. Alopecia Areata Research Summit – Product Innovation Ecosystem Determining Clinical Research Approach for Product Innovation • Key role for clinical outcome assessments in the path to regulatory approval – Identifying what aspects of the disease need to be altered as priority by a new therapy – Determining how to measure whether an intervention improves a disease dimension • Validated outcome measures for treatments are important for – Technical stream: e.g. for health authority product approval – Financial stream: e.g. for determining a product’s value to patients and payers • Particularly important without previous regulatory approvals and market launches11 Basic Research Biology Target ID Target Validatio n Chemistry Development Approve d DrugScreening Optimization Pre- clinical Phase I Phase II Phase III FDA review Eureka ! O OCH3 OCH3 OCH3 OH
  • 12. Other Elements for Product Innovation Inventions, Products, and Assets Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist 12 Technical Stream Financial Stream O OCH3 OCH3 OCH3 OH Product Asset
  • 13. Advancing Product Development A Team Sport Support and Enablement from the Ecosystem Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist 13 Technical Stream Financial Stream O OCH3 OCH3 OCH3 OH Product Asset
  • 14. Cosmetics Devices Diagnostics Drugs/Biotechnology eHealth Govt / Nonprofit Investor OTC Physician/Academician Service Provider Company/Organization Representation ~300 Registrants Annual Dermatology Innovation Forum Attendee Composition (March 2016 ) 14 Participants include: • Technical Stream – Physicians – Researchers – Inventors – Government regulators • Financial Steam – Investors – Strategic corporate partners • Bridging stakeholders – Patient advocates – Service providers
  • 15. Sponsors of the 2017 Dermatology Summit & Dermatology Innovation Forum LEADERSHIP MAJOR FOUNDING SUPPORTING Conference Benefactor PREMIER Conference Benefactor Conference Benefactor Conference Benefactor Conference Benefactor
  • 16. Support and Enablement from the Ecosystem Alopecia Areata Example Research Center / Entrepreneur Discovery Regulatory Approval Invention Commer- cialization Late DevelopmentClinical POCEarly Development Venture Capital Firm Strategic Partner Angel Investor / Patient Advocacy / Impact Philanthropist 16 Technical Stream Financial Stream O OCH3 OCH3 OCH3 OH Product Asset
  • 17. Building an Ecosystem to Enable, Encourage and Support New Products for AA • Purposeful, proactively-built ecosystems can help enable productive collaboration for advancing product innovation for substantially improving dermatologic health • Alopecia Areata Research Summit participants and NAAF are to be commended for your – Patient focus, breakthrough bench & clinical research, and other contributions – Collaborative interactions and ecosystem building for bringing forth important and impactful products for alopecia areata patients 17